Omega Cuff for GERD Feasibility Study

Eligibility Criteria

• * • Subject must be at least 22 years of age and must be less than 75 years of age with a life expectancy \> 3 years.
• * Subject is a suitable surgical candidate, i.e., is able to undergo general anesthesia and laparoscopic surgery.
• * Subject has documented typical symptoms of gastroesophageal reflux disease (GERD) for longer than 6 months (regurgitation or heartburn that is defined as a burning epigastric or substernal pain that responds to acid neutralization or suppression).
• * Subject requires daily proton pump inhibitor or other anti-reflux drug therapy.
• * Total Distal Ambulatory Esophageal pH must meet the following criteria: pH\< 4 for ≥ 4.5% of the time Note: Subjects will have discontinued any GERD medications for at least 10 days prior to testing.
• * Subject has a symptomatic improvement on proton-pump inhibitor (PPI) therapy demonstrated by a GERD-Health-Related Quality of Life (GERD-HRQL) score of ≤ 10 on proton-pump inhibitors and ≥ 15 off PPIs, or subjects with a ≥ 6-point improvement when comparing his/her on-PPI and off-PPI GERD-HRQL score.
• * Subject has GERD symptoms in absence of PPI therapy (minimum 10 days).
• * If the subject is of child-bearing potential, she must have a negative pregnancy test within one week prior to implant and must agree to use effective means of birth control during the course of the study.
• * Subject is willing and able to cooperate with follow-up examinations.
• * Subject has been informed of the study procedures and the treatment and has signed an informed consent form.
• * • The procedure is an emergency procedure.
• * Subject is currently being treated with another investigational drug or investigational device.
• * Subject has a history of gastroesophageal surgery, anti-reflux procedures, or gastroesophageal/gastric cancer.
• * Subject has undergone any previous endoscopic anti-reflux intervention for GERD.
• * Subject has suspected or confirmed esophageal or gastric cancer.
• * Subject has any size hiatal hernia \>3cm as determined by endoscopy.
• * Distal esophageal motility (average of sensors 3 and 4) is less than 35 mmHg peristaltic amplitude on wet swallows or \<70% (propulsive) peristaltic sequences.
• * Subject has esophagitis Grade C or D (LA Classification).
• * Subject has a Body Mass Index (BMI)\>35.
• * Subject has symptoms of dysphagia more than once per week within the last 3 months.
• * Subject is diagnosed with Scleroderma or an esophageal motility disorder such as but not limited to Achalasia, Nutcracker Esophagus, or Diffuse Esophageal Spasm or Hypertensive LES.
• * Subject has a history of or known esophageal stricture or gross esophageal anatomic abnormalities (Schatzki's ring, obstructive lesions, etc.).
• * Subject has esophageal or gastric varices.
• * Subject has a history of or known Barrett's esophagus.
• * Subject cannot understand trial requirements or is unable to comply with the follow-up schedule.
• * Subject is pregnant or nursing or plans to become pregnant during the course of the study.
• * Subject has a medical illness (e.g., congestive heart failure) that may cause the subject to be non-compliant with or unable to meet the protocol requirements or is associated with limited life expectancy (i.e., less than 3 years).
• * Subject is diagnosed with a psychiatric disorder (e.g., bipolar, schizophrenia, etc.); however, subjects who exhibit depression but are on appropriate medication(s) may be included.
• * Subject has suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials.
• * Subject has an electrical implant or metallic abdominal implants.
• * Subject is not a surgical candidate for open laparotomy.